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Sem Barendse
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Decks in this class (17)
7 januariIntroduction to Clinical Trials
What are ophan diseases 1,
Efficacy 2,
Effectiveness 3
11
cards
7 jan: Clinical Research History, guidelines & regulations
Incident following wwii where pri...,
Incident softenon thalidomide chi...,
Indicent 1937 elixir sulfanilamid...
21
cards
9 januari: lifecycle of a drug
What do you need to prove to obta...,
What makes drug development diffi...,
What is the difference between me...
12
cards
9 januari: Lifecycle of a clinical trial
Main do you understand the flowch...,
Currently two database from the e...
2
cards
10 januari: methodology
Methodology is related to which g...,
Direction of ich e9 bias precisio...,
Define bias and describe its poss...
17
cards
10 januari: Clinical Trial approvals
What are the steps in maa 1,
Why would you opt to go for eithe...,
What are the fda tasks 5 3
12
cards
10 januari: Recruitment and informed consent
Which code regulation initiated i...,
What has to be included in inform...,
Name the two types of informed co...
4
cards
10 januari: Pharmacovigilance
Eric made a mental note for a pos...,
Define ae and give an example 2,
Define adr and give an example 3
7
cards
17 januari: ICH-GCP
Which actor is missing in the int...,
Can every country join in the ich 2,
The ich guide line had qsem topic...
16
cards
17 januari: GCP responsibilities
What are the differences 2 in res...,
In the review of an ethical submi...,
Name the 5 investigator obligatio...
17
cards
17 januari: Risk-based Quality Management
Why is it essential to conduct pr...,
Name and describe the 7 required ...,
What are the four types of risk i...
6
cards
17 januari: Quality control, Quality assurance & Site audits
What is the difference between qu...,
What is qc 2,
What is qa 3
6
cards
17 januari: Fraud & Misconduct
What is the difference between fr...,
Provide examples and exemplify th...,
How did the ich gcp tried to prev...
4
cards
21 januari: Virtual Trials
Name challenges related to virtua...,
Name opportunities related to vir...,
What is according to eric the ult...
4
cards
21 januari: Patient-centric trials
What is the main objective of pat...,
Name patient centric trial relate...,
Name patient centric trial relate...
3
cards
21 januari: Personalized medicine
Name challenges related to person...,
Name opportunities related to per...
2
cards
Mock exam/possible exam questions
Which laws apply when you want to...
1
cards
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Clinical Trials
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